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Anti-diabetic agent
Empagliflozin for Obesity-Related Inflammation (SADIE2 Trial)
Phase 1 & 2
Recruiting
Led By Monda Mashayekhi, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 70 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
SADIE2 Trial Summary
This trial will study if an anti-diabetes drug can reduce inflammation in obese people, which could help prevent heart disease.
Who is the study for?
This trial is for adults aged 18-70 with metabolic syndrome, defined by high blood pressure, elevated triglycerides, low HDL cholesterol, high fasting blood sugar or large waist circumference. Participants must have a BMI ≥ 35 kg/m2 and be planning obesity surgery within the next 90-150 days. Exclusions include alcohol/drug abuse history, pregnancy/breastfeeding without contraception, type 1 diabetes or recent SGLT2 inhibitor use.Check my eligibility
What is being tested?
The study tests whether Empagliflozin (a drug that lowers blood sugar) can reduce inflammation in fat tissue and improve heart-related functions in obese patients. It's a randomized controlled trial where participants will either receive Empagliflozin or a placebo to compare effects.See study design
What are the potential side effects?
Potential side effects of Empagliflozin may include genital infections in men and women, urinary tract infections, dehydration symptoms like hypotension (low blood pressure), ketoacidosis (high levels of acid in the blood), and possible allergic reactions.
SADIE2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
SADIE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adipose tissue macrophages
Flow mediated dilation
Monocyte chemoattractant protein-1
Secondary outcome measures
IL-6
Pro-inflammatory T cells
SADIE2 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Empagliflozin ArmActive Control1 Intervention
Empagliflozin is an FDA-approved SGLT2 inhibitor used for the treatment of type 2 diabetes, with off-label use for diabetic kidney disease and for heart failure with reduced ejection fraction even in those without diabetes. To ensure blinding, empagliflozin will be over-encapsulated in identical gelatin capsules as placebo.
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo consists of gelatin capsules.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
673,079 Total Patients Enrolled
8 Trials studying Metabolic Syndrome
570 Patients Enrolled for Metabolic Syndrome
Monda Mashayekhi, MDPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not well-managed, with an HbA1c level of 9% or higher.I am not pregnant or breastfeeding and use effective birth control or am surgically sterilized.I have advanced liver disease with cirrhosis.I have only used metformin or a sulfonylurea for my diabetes in the last month.My kidney function, measured by eGFR, is below 45 mL/min/1.73 m2.You have a heart device like a pacemaker or defibrillator implanted.I have had a serious brain condition like a stroke or mini-stroke.You have three or more of the following: high blood pressure, high triglycerides, low HDL cholesterol, high blood sugar, or a large waist size.I have been on long-term steroid treatment for more than a week in the past month.I have not had a heart attack or serious heart issues in the last 6 months.I have a stomach or bowel problem that affects how medicines work in my body.Criterion Related to Known Adverse Effects of Drug: You have specific medical conditions or history of reactions that could be made worse by the study medications, including certain infections, urinary tract issues, blood pressure problems, and allergies to the trial medications or similar products.I have had pancreatitis or surgery on my pancreas.You have Type 1 diabetes.I have taken an SGLT2 inhibitor in the past 3 months.I am currently taking blood thinners.I understand the details and risks of the study.I don't have any health conditions that my medication can't control during the study.I have a history of immune or blood disorders.I am between 18 and 70 years old.You have a history of drinking more than 14 alcoholic drinks per week (for men) or more than 7 alcoholic drinks per week (for women), or using illegal drugs.I have not taken any GLP-1 receptor agonist drugs in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin Arm
- Group 2: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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